NCT06834386

Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients

A Pilot Randomized, Open Label Trial of Orexin Receptor Antagonist for Insomnia in Hospitalized Patients With Cancer to Prevent Delirium

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase IV trial compares suvorexant with standard of care to standard of care alone for improving difficulty sleeping (insomnia) and reducing confusion (delirium) in hospitalized cancer patients. Delirium can lengthen hospitalization, increase the delay of cancer treatment and can even increase the risk of premature death. Suvorexant is in a class of medications called orexin receptor antagonists. It works by blocking the action of a certain natural substance in the brain that causes wakefulness. Giving suvorexant with standard of care to treat insomnia may be more effective compared to standard of care alone in reducing the development of delirium in hospitalized cancer patients.

Detailed description

PRIMARY OBJECTIVE: I. Feasibility of a subsequent full scale randomized clinical trial (RCT) conducted at Mayo Clinic using the same methodology as outlined in this protocol (as this study is a pilot). SECONDARY OBJECTIVE: I. To generate preliminary data to determine if inpatient standard of care (i.e. sleep enhancement) is followed in both a study arm receiving standard of care alone and one receiving standard of care plus suvorexant. EXPLORATORY OBJECTIVES: I. To collect preliminary data to investigate the hypotheses that use of suvorexant in addition to standard of care for hospitalized adults with cancer will result in a decreased incidence of delirium, increased time to onset of delirium, and decreased number of delirium days in hospital as compared to standard of care alone. II. To build a data collection and analysis infrastructure for a full scale RCT at Mayo Clinic if feasibility is demonstrated. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive suvorexant orally (PO) once daily (QD) at bedtime and standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity. ARM II: Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.

Conditions

• Advanced Malignant Solid Neoplasm
• Delirium
• Hematopoietic and Lymphatic System Neoplasm
• Insomnia

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard of care
OTHER	Electronic Health Record Review	Ancillary studies
OTHER	Interview	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Suvorexant	Given PO

Timeline

• Start date: 2025-02-26
• Primary completion: 2025-04-24
• Completion: 2025-04-24
• First posted: 2025-02-19
• Last updated: 2025-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study